Ketamine on Acute Pain in Females and Males
Brief Summary
The purpose of the study is to determine whether equal subanesthetic doses of racemic ketamine is equally effective on females and males after surgical removal of third molars
Intervention / Treatment
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Placebo males (DRUG)Intravenous saline bolus (Placebo-control) males
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Ketamine 0,1 mg/kg males (DRUG)0,1 mg/kg ketamine iv bolus males
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Ketamine 0,3 mg/kg males (DRUG)0,3 mg/kg ketamine iv bolus males
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Ketamine 0,5 mg/kg males (DRUG)0,5 mg/kg ketamine iv bolus males
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Placebo females (DRUG)Intravenous saline bolus (Placebo-control) females
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Ketamine 0,1 mg/kg females (DRUG)0,1 mg/kg iv bolus ketamine females
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Ketamine 0,3 mg/kg females (DRUG)0,3 mg/kg iv bolus ketamine females
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Ketamine 0,5 mg/kg females (DRUG)0,5 mg/kg iv bolus ketamine females
Condition or Disease
- Mouth and Tooth Diseases
- Tooth, Impacted
Phase
Study Design
Study type: | INTERVENTIONAL |
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Status: | Completed |
Study results: | No Results Available |
Age: | 20 Years to 30 Years |
Enrollment: | 128 (ACTUAL) |
Funded by: | Other |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking |
Clinical Trial Dates
Start date: | Jan 01, 2005 | |
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Primary Completion: | Nov 01, 2006 | ACTUAL |
Completion Date: | Nov 01, 2006 | ACTUAL |
Study First Posted: | Oct 04, 2005 | ESTIMATED |
Results First Posted: | Aug 31, 2020 | |
Last Updated: | Jul 03, 2011 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
Ketamine is assumed to be a NMDA receptor antagonist which provides analgesia from acute postoperative pain(and other types of pain) subanesthetic doses. Gender differences in ketamine analgesia are not known. This placebo-controlled,randomised, parallel group study investigates the analgesic dose-response effect of ketamine in subanesthetic doses in female and male patients following surgical removal of third molars.
Comparisons: Placebo and ketamine in females and males.
Comparisons: Placebo and ketamine in females and males.
Eligibility Criteria
Sex: | All |
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Minimum Age: | 20 |
Maximum Age: | 30 |
Healthy Volunteers: | Yes |
Inclusion Criteria:
* Indication for removal of third molar
* Between 20 and 30 years of age
* ASA Class 1
Exclusion Criteria:
* Psychiatric family (father/mother) or own anamnestic history
* Hypersensitivity towards NSAIDS or other rescue analgesics
* Verified or suspected pregnancy
* Lactating females
* Surgery lasting over 60 min
* Indication for removal of third molar
* Between 20 and 30 years of age
* ASA Class 1
Exclusion Criteria:
* Psychiatric family (father/mother) or own anamnestic history
* Hypersensitivity towards NSAIDS or other rescue analgesics
* Verified or suspected pregnancy
* Lactating females
* Surgery lasting over 60 min
Primary Outcomes
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Sum pain NRS 60 min
Secondary Outcomes
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Several subjective variables assessing psychotomimetic effects 0, 15, 60
More Details
NCT Number: | NCT00232492 |
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Other IDs: | DOK-015 |
Study URL: | https://clinicaltrials.gov/study/NCT00232492 |
Last updated: Sep 29, 2023